BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 13650756 · Received March 2, 2022

    Report

    Report Number
    9612164-2022-00846
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    March 30, 2021
    Report Date
    April 25, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL ARTICLE: PROXIMAL OPTIMISATION TECHNIQUE VERSUS FINAL KISSING BALLOON INFLATION IN CORONARY BIFURCATION LESIONS: THE RANDOMISED, MULTICENTRE PROPOT TRIAL AUTHORS: WATANABE, YUSUKE; MURASATO, YOSHINOBU; YAMAWAKI, MASAHIRO; KINOSHITA, YOSHIHISA; OKUBO, MUNENORI; YUMOTO, KAZUHIKO; MASUDA, NAOKI; OTAKE, HIROMASA; AOKI, JIRO; NAKAZAWA, GAKU; NUMASAWA, YOHEI; ITO, TATSUYA; SHITE, JUNYA; OKAMURA, TAKAYUKI; TAKAGI, KENSUKE; KOZUMA, KAYOKO; LEFVRE, THIERRY; CHEVALIER, BERNARD; LOUVARD, YVES; SUZUKI, NOBUAKI; KOZUMA, KEN; WATANABE, YUSUKE JOURNAL: EUROINTERVENTION YEAR: 2021 REFERENCE: 10.4244/EIJ-D-20-01386. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX D CODE ADDED MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    AN ARTICLE TITLED - PROXIMAL OPTIMIZATION TECHNIQUE VERSUS FINAL KISSING BALLOON INFLATION IN CORONARY BIFURCATION LESIONS: THE RANDOMIZED, MULTICENTER PROPOT TRIAL - WAS SUBMITTED FOR REVIEW. THE AIM OF THE STUDY WAS TO INVESTIGATE WHETHER PROXIMAL OPTIMIZATION TECHNIQUE (POT) WAS SUPERIOR IN TERMS OF STENT APPOSITION COMPARED WITH THE CONVENTIONAL KISSING BALLOON TECHNIQUE (KBT) IN REAL LIFE BIFURCATION LESIONS USING OPTICAL COHERENCE TOMOGRAPHY (OCT). 120 PATIENTS WERE INCLUDED IN THE PROSPECTIVE STUDY AND RANDOMIZED INTO TWO GROUPS FOR PCI BETWEEN APRIL 2016 AND JULY 2018. ALL PATIENTS HAD EITHER A RESOLUTE INTEGRITY OR A RESOLUTE ONYX DRUG ELUTING STENT IMPLANTED. THE FIRST GROUP WAS THE POT FOLLOWED BY SIDE BRANCH DILATION GROUP AND INCLUDED A FINAL NUMBER OF 57 PATIENTS. THE FINAL NUMBER OF 58 PATIENTS OF THE SECOND GROUP UNDERWENT KBT. THE PRIMARY ENDPOINT OF THE STUDY WAS THE RATE OF MALAPPOSED STRUTS ASSESSED BY THE FINAL OCT. THE RATE OF MALAPPOSED STRUTS DID NOT DIFFER BETWEEN THE TWO GROUPS. MORE ADDITIONAL TREATMENTS WERE REQUIRED AMONG THE POT GROUP. ONE YEAR CLINICAL OUTCOMES INCLUDED ONE MYOCARDIAL INFARCTION, CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (TLR), MAIN VESSEL IN-STENT RESTENOSIS, PROXIMAL EDGE RE-STENOSIS AND TARGET VESSEL REVASCULARIZATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340037 RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention